LZI — Device, Assistive Listening Class II
FDA product code LZI covers "Device, Assistive Listening", a Class II medical device regulated under 21 CFR 874.3320. Submissions are reviewed by the Ear, Nose, Throat panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZI
- Device Class
- Class II
- Regulation Number
- 874.3320
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K043090 | phonic ear | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | December 23, 2004 |
| K970974 | williams sound | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER | May 2, 1997 |
| K970340 | bellab | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER | March 26, 1997 |
| K954748 | williams sound | POCKETALKER PRO | November 22, 1995 |
| K952057 | national hearing aid dist | LISTENAIDER II | June 21, 1995 |
| K934805 | je liss and co | HEARIT | February 7, 1994 |
| K904755 | krueger laboratories | ACOUSTIQ LISTENING DEVICE | January 29, 1991 |